These seven companies are bound by the license in a market which essentially is open. And it is a huge market with nearly 18 million Hepatitis C patients in India itself with estimates suggesting a USD 2-3 billion market opportunity. Delhi HC has sought more details and will next hear the matter on January 30.
Gilead challenges Patent Controller’s rejection of Sovaldi Gilead challenged Patent Controller’s order that said Sovaldi (or Sofosbuvir) was not inventive enough under section 3 (d) of the Indian Patent Act.
Gilead Sciences is not taking the Indian Patent Controller’s rejection of its Hepatitis C wonder drug lying down. The US drug maker has challenged the patent denial order in Delhi High Court on grounds that the order is beyond comprehension.
Gilead challenged Patent Controller’s order that said Sovaldi (or Sofosbuvir) was not inventive enough under section 3 (d) of the Indian Patent Act.
Gilead has argued that the order is beyond comprehension, as on one hand it disposes off the inventiveness argument while on the other hand it issues notice on the opposition for further proceeding and therefore, cannot stand at all in law.
The order has received criticism from neutral legal quarters for being unclear, particularly on how it treats the requirement for inventiveness and increased therapeutic value of the drug. Also, the case has huge market impact. Gilead is preparing to launch Sovaldi in India, at a fraction of its USD 1,000 a day US price tag but the patent denial just opened up the market for even cheaper generics which will be a big positive for Hepatitis C patients.
The case also impacts seven other drugmakers like Cipla, Ranbaxy, Hetero who have signed voluntary licenses with Gilead to launch Sofosbuvir in 91 low income countries, including India.